A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.

At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

The Change in Fasting Triglyceride Level From Baseline to Week 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Drug: DRV/r

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Switch to ATV/r (300mg/100mg QD)

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this are the subject switched to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study

Drug: ATV/r

Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Other Name: Atazanavir/r

Detailed Description:

This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and > or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to screening.

Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL<400 copies/ml) using an FDA approved assay for a minimum of twelve weeks prior to screening AND undetectable HIV viral load using an FDA approved ultrasensitive assay at screening.

No evidence of HIV protease resistance as defined by the Stanford HIV database

Currently receiving first protease inhibitor unless switch to LPV/r or FPV/r was for non-virologic reasons

Fasting triglycerides > 200 mg/dL

No ongoing issues that in the opinion of the investigator would lead to decreased ability to comply with the study procedures

If currently receiving a proton pump inhibitor, the dose is < omeprazole 20 mg or the equivalent dose of another proton pump inhibitor

If patient is receiving another lipid lowering medication, it must be at a stable dose

Exclusion Criteria:

Currently receiving an ART regimen other than > or equal to two NRTIs and either LPV/r or FPV/r

Note: Individuals co-infected with chronic hepatitis B or C viruses will be allowed to enter the trial if their condition is clinically stable and they will not require therapy during the course of the study. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase

Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance

Use of any investigational agents 30 days prior to screening

Life expectancy < 6 months in the opinion of the investigator

Pregnancy or breast feeding

Female subject of childbearing potential (i.e., heterosexually active, and not surgically sterile or at least two years post-menopausal) not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756730

Locations

United States, Arizona

Spectrum Medical Group

Phoenix, Arizona, United States, 85012

United States, California

AIDS Healthcare Foundation

Los Angeles, California, United States, 02319

United States, Florida

Orlando Immunology Center

Orlando, Florida, United States, 32803

United States, Massachusetts

Community Research Initiative

Boston, Massachusetts, United States, 02215

Community Research Initiative - West

Springfield, Massachusetts, United States, 01107

United States, Minnesota

Abbott Northwestern Infectious Disease and Travel Clinic

Minneapolis, Minnesota, United States, 55404

United States, New York

AIDS Community Health Center

Rochester, New York, United States, 14804

United States, Pennsylvania

Philadelphia Fight

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

David M. Lee, M.D., P.A., a/b/a Uptown Physicians Group

Dallas, Texas, United States, 75204

Nicholaos C. Bellos, MD, PA

Dallas, Texas, United States, 75204

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Daniel Skiest, MD

Tibotec Pharmaceutical Limited

Investigators

Principal Investigator:

Daniel J Skiest, MD

Community Research Initiative

More Information

No publications provided

Responsible Party:

Daniel Skiest, MD, Associate Research Director, Community Research Initiative of New England